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AMOXICILLIN 250 MG CAPSULES

Active substance(s): AMOXICILLIN TRIHYDRATE

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Amoxicillin 250mg
Capsules
Amoxicillin 500mg
Capsules
(amoxicillin)

Read all of this leaflet carefully before
you start taking this medicine.
- Keep this leaflet. You may need to
read it again.
- If you have any further questions, ask
your doctor or pharmacist.
- This medicine has been prescribed for
you only. Do not pass it on to
others. It may harm them, even if their
signs of illness are the same
as yours.
- If you get any side effects, talk to your
doctor or pharmacist. This includes
any possible side effects not listed in
this leaflet. See section 4
In this leaflet:
1. What Amoxicillin Capsules are and
what they are used for
2. What you need to know before you
take Amoxicillin Capsules
3. How to take Amoxicillin Capsules
4. Possible side effects
5. How to store Amoxicillin Capsules
6. Contents of the pack and other
information
1. WHAT AMOXICILLIN CAPSULES
ARE AND WHAT THEY ARE USED
FOR
Amoxicillin Capsules contain amoxicillin
as the active ingredient which belongs to
a class of antibiotics called ‘penicillins’.
Amoxicillin Capsules are used to treat
infections caused by bacteria in different
parts of the body. Amoxicillin capsules
may also be used in combination with
other medicines to treat stomach ulcers.
2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE AMOXICILLIN
CAPSULES
Do not take Amoxicillin Capsules
• if you are allergic to amoxicillin,
penicillin or any of the other
ingredients of this medicine (listed in
section 6)
• if you have ever had an allergic
reaction to any antibiotic. This can
include a skin rash or swelling of the
face or throat
Do not take Amoxicillin if any of the
above apply. If you are not sure, talk
to your doctor or pharmacist before
taking amoxicillin.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Amoxicillin Capsules if you:
• suffer from kidney problems, since you
may need a lower dose.
• have glandular fever (fever, sore
throat, swollen glands and extreme
tiredness), lymphatic leukemia or HIV
infection, since you may be more
prone to developing a skin rash.
• are not urinating regularly
If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before taking Amoxicillin.
Having urine or blood tests
If you are having:
• Urine tests (glucose) or blood tests for
liver function
• Oestriol tests (used during pregnancy
to check the baby is developing
normally)
Tell your doctor or pharmacist that you
are taking Amoxicillin. This is because
Amoxicillin can affect the results of these
tests.
Other medicines and Amoxicillin
Capsules
Tell your doctor or pharmacist if you are
taking, have recently taken or might
take any other medicines.
• If you are taking allopurinol (used for
gout) with Amoxicillin, it may be more
likely that you will have an allergic skin
reaction.
• If you are taking probenecid (used for
gout), your doctor may decide to adjust
the dose of Amoxicillin.
• If you are taking medicines to help stop
blood clots (such as warfarin), you may
need extra blood tests.
• If you are taking other antibiotics (such
as tetracycline) Amoxicillin may be less
effective.
• If you are taking methotrexate (used
for the treatment of cancer and severe
psoriasis) Amoxicillin may cause an
increase in side effects.
Amoxicillin Capsules with food and
drink
These capsules may be taken before,
during or after your meals.

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Pregnancy and breast-feeding
If you are pregnant or breast-feeding,
think you may be pregnant or are planning
to have a baby, ask your doctor or
pharmacist for advice before taking this
medicine. Amoxicillin passes into breast
milk, so tell your doctor if you are breastfeeding. Ask your doctor for advice before
taking any medicine.
Driving and using machines
Amoxicillin can have side effects
and the symptoms (such as allergic
reactions,dizziness and convulsions) may
make you unfit to drive. Do not drive or
operate machinery unless you are feeling
well.
3. HOW TO TAKE AMOXICILLIN
CAPSULES
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.
- Swallow with water without opening
capsule.
- Space the doses evenly during the
day, at least 4 hours apart.
Children weighing less than 40kg who
are able to swallow capsules
All doses are worked out depending on
the child’s body weight in kilograms.
• Your doctor will advise you how much
Amoxicillin capsules you should give to
your baby or child.
• Usual dose - 40mg to 90mg for each
kilogram of body weight a day, given in
two or three divided doses.
• The maximum recommended dose
is 100mg for each kilogram of body
weight a day.
Adults, elderly patients and children
weighing 40 kg or more
The usual dose of Amoxicillin is 250 mg to
500 mg three times a day or 750 mg to 1 g
every 12 hours, depending on the severity
and type of infection.
• Severe infections: 750 mg to 1 g
three times a day
• Urinary tract infection: 3 g twice daily
for one day.
• Lyme disease (an infection spread
by parasites called ticks): Isolated
erythema migrans (early stage - red or
pink circular rash): 4 g a day,
Systemic manifestations (late stage for more serious symptoms or when
the disease spreads around yur body):
up to 6 g a day.
• Stomach ulcers: one 750 mg or one
1 g dose twice a day for 7 days with
other antibiotics and medicines to treat
stomach ulcers.
• To prevent heart infection during
surgery: the dose will vary according
to the type of surgery. Other medicines
may also be given at the same time.
Your doctor, pharmacist or nurse can
give you more details.
• The maximum recommended dose is
6 g per day.
Kidney problems
If you have kidney problems the dose
might be lower than the usual dose.
If you take more Amoxicillin Capsules
than you should
If you have taken too much Amoxicillin
capsules, signs might be an upset
stomach (feeling sick, being sick or
diarrhoea) or crystals in the urine, which
may be seen as cloudy urine, or problems
urinating. Talk to your doctor as soon as
possible. Take the medicine to show the
doctor.
If you forget to take Amoxicillin
Capsules
If you miss a dose, take it as soon as you
remember and carry on as before. If it is
almost time for your next dose, skip the
missed dose and continue as usual. Do
not take a double dose to make up for a
forgotten dose.
How long should you take amoxicillin
for?
• Keep taking amoxicillin until the
treatment is finished, even you feel
better. You need every dose to help
fight the infection. If some bacteria
survive they can cause the infection
to come back. Treatment should
be continued for 2 to 3 days after
symptoms have gone.
• You should not need to take amoxicillin
for more than 2 weeks. If you still feels
unwell you should go back to see your
doctor.
Thrush (a yeast infection of moist areas of
the body which can cause soreness,
itching and white discharge) may
develop if Amoxicillin is used for
a long time. If this occurs tell your
doctor.

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

If you have any further questions
on the use of this medicine, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Amoxicillin Capsules
can cause side effects, although not
everyone gets them.
Stop taking Amoxicillin capsules and
see a doctor straight away, if you
notice any of the following serious side
effects - you may need urgent medical
treatment:
The following are very rare (may affect up
to 1 in 10,000 people)
• allergic reactions, the signs may
include: skin itching or rash, swelling of
the face, lips tongue, body or breathing
difficulties. These can be serious and
occasionally deaths have occurred
• Rash or pinpoint flat red round spots
under the skin surface or bruising of
the skin. This is due to an inflammation
of blood vessel walls due to an allergic
reaction. It can be associated with joint
pain (arthritis) and kidney problems.
• A delayed allergic reaction can
occur usually 7 to 12 days after
having amoxicillin, some signs
include: rashes, fever, joint pain and
enlargement of lymph nodes especially
under the arms
• A skin reaction known as ‘erythema
multiforme’ where you may develop:
itchy reddish purple patches on the
skin especially on the palms of the
hands or soles of the feet, ‘hive-like’
raised swollen areas on the skin,
tender areas on the surfaces of the
mouth, eyes and genitals. You may
have a fever and be very tired.
• Other severe skin reactions can
include: changes in skin colour, bumps
under the skin, blistering, pustules,
peeling, redness, pain, itching, scaling.
These may be associated with fever,
headaches and body aches.
• fever, chills, a sore throat or other
signs of an infection, or if you bruise
easily. These may be signs of a
problem with your blood cells
• flu-like symptoms with a rash, fever,
swollen glands, and abnormal blood
test results (including increased
white blood cells (eosinophilia) and
liver enzymes) (Drug Reaction with
Eosinophilia and Systemic Symptoms
(DRESS)).
• the Jarisch-Herxheimer reaction
which occurs during treatment with
Amoxicillin for Lyme disease and
cause fever, chills, headache, muscle
pain and skin rash.
• inflammation of the large bowel (colon)
with diarrhoea (sometimes containing
blood), pain and fever
• serious liver side effects may occur.
They are mainly associated with
people having treatment over a long
period, males and the elderly. You
must tell your doctor urgently if you
get:
• severe diarrhoea with bleeding
• blisters, redness or bruising of the
skin
• darker urine or paler stools
• yellowing of the skin or the whites
of the eyes (jaundice). See also
anaemia below which might result
in jaundice.
These can happen when having the
medicine or for up to several weeks after.
If any of the above happens stop taking
the medicine and see your doctor
straight away.
Sometimes you may get less severe
skin reactions such as:
• a mildly itchy rash (round, pink-red
patches), ‘hive-like’ swollen areas on
forearms, legs, palms, hands or feet.
This is uncommon (may affect up to 1
in 100 people).
If you have any of these talk to your
doctor as Amoxicillin will need to be
stopped.
The other possible side effects are:
Common (may affect up to 1 in 10 people)
• skin rash
• feeling sick (nausea)
• diarrhoea
Uncommon (may affect up to 1 in
100 people)
• being sick (vomitting).
Very rare (may affect up to 1 in
10,000 people)
• thrush (a yeast infection of the vagina,
outh or skin folds), you can get
treatment for thrush from your doctor
or pharmacist
• kidney problems
• fits (convulsions), seen in patients on
high doses or with kidney problems





dizziness
hyperactivity
crystals in the urine, which may be
seen as cloudy urine, or difficulty or
discomfort in passing urine. Make sure
you drink plenty of fluids to reduce
the chance of these symptoms.
• the tongue may change to yellow,
brown or black and it may have a hairy
appearance.
• an excessive breakdown of red blood
cells causing a type of anaemia.
Signs include: tiredness, headaches,
shortness of breath, looking pale and
yellowing of the skin and the whites of
the eyes.
• low number of white blood cells
• low number of cells involved with blood
clotting
• the blood may take longer to clot than
it normally would. You may notice
this if you have a nosebleed or cut
yourself.
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme: www.
mhra.gov.uk/yellowcard or search for
MHRA Yellow Card in the Google Play or
Apple App Store. By reporting side effects
you can help provide more information on
the safety of this medicine.
5. HOW TO STORE AMOXICILLIN
CAPSULES
Keep this medicine out of the sight and
reach of children.
Do not store above 25°C.
Store the capsules in their original
package and keep containers tightly
closed.
Use Amoxicillin Capsules before the expiry
date shown on the label. The expiry date
refers to the last day if the month.
Medicines should not be disposed of via
wastewater or household waste.
Ask your pharmacist how to dispose of
medicines no longer required. These
measures will help to protect the
environment.
6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Amoxicillin Capsules contain
The active substance is amoxicillin
trihydrate
each 250mg capsule contains 250mg
amoxicillin trihydrate.
each 500mg capsule contains 500mg
amoxicillin trihydrate.
The other ingredients are magnesium
stearate (E572), colloidal anhydrous
silica, titanium dioxide (E171), iron oxides
red (E172), iron oxides yellow (E172),
erythrosine (E127), indigo-carmine
(E132) and gelatin. The ink is composed
of shellac, dehydrated alcohol, isopropyl
alcohol, butyl alcohol, propylene glycol,
strong ammonia solution, potassium
hydroxide, black iron oxide (E172).
What Amoxicillin Capsules look like
and contents of the pack
Amoxicillin 250mg Capsule are white to
off-white granular powder filled in hard
gelatine capsule shells size ‘2’. Scarlet
colour cap, buff colour body printed with
‘AMOXY’ on cap and ‘250’ on body.
Amoxicillin 500mg Capsules are white to
off-white granular powder filled in hard
gelatine capsule shells size ‘0’. Scarlet
colour cap, buff colour body printed with
‘AMOXY’ on cap and ‘500’ on body.
Both products are available in container
packs of 15, 20, 21, 100, 500 and 1000
capsules as well as blister strips of 15 and
21 capsules (not all pack sizes may be
marketed).
Amoxicillin 250mg Capsules are also
available in container pack of 50 capsules.
Marketing Authorisation Holder:
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip, HA4 6QD
United Kingdom
Manufacturers:
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip, HA4 6QD
United Kingdom
APL Swift Services (Malta) Ltd.,
HF26, Hal Far Industrial Estate,
HalFar, Birzebbugia BBG 3000
This leaflet was last revised in 10/2017

P15XXXXX

If you take Amoxicillin for a long
time, your doctor may perform
additional tests to check your
kidneys, liver and blood are
working normally.

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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